Actively Recruiting
Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer Employing Radiation, Immuno-oncology and Resection
Led by Marc de Perrot · Updated on 2024-07-22
12
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
M
Marc de Perrot
Lead Sponsor
O
Ozmosis Research Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The SUPER trial is a prospective Phase II trial. It is designed for patients with stage 2 or 3 non-small cell lung cancer (NSCLC) prior to surgery. Patients who are enrolled in this trial will receive combination of Non-ablative oligofractionated radiation (NORT) and two cycles of Durvalumab, an immunotherapy drug before their surgery.
CONDITIONS
Official Title
Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer Employing Radiation, Immuno-oncology and Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and comply with study requirements
- Age over 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Body weight over 30 kg
- Adequate organ and marrow function including hemoglobin 6 g/dL, ANC 1.0 �d7 10^9/L, platelet count 75 �d7 10^9/L, normal bilirubin (except Gilbert's syndrome with doctor approval), AST/ALT 2.5 times institutional upper limit
- Creatinine clearance over 40 mL/min
- Willing and able to follow study protocol including treatment and visits
- Life expectancy of at least 12 weeks
- Tumor suitable for biopsy
- Diagnosed with NSCLC stage IIB to IIIB
- PD-L1 positive tumors with tumor proportion score over 1%
- Suitable for surgery and combined therapy per investigator's opinion
- Anticipated complete R0 tumor and lymph node removal based on baseline evaluation
You will not qualify if you...
- Participated in another investigational study within 8 weeks before enrollment
- Concurrent enrollment in other interventional studies (except observational or follow-up)
- Known EGFR or ALK oncogenic driver mutations
- Presence of N3 disease in contralateral mediastinum, hilum, or supraclavicular lymph nodes
- Unresolved toxicity Grade 2 from prior cancer therapy except alopecia, vitiligo, or defined lab values
- Concurrent chemotherapy, investigational product, biologic, or hormonal cancer treatments
- Major surgery within 28 days before first durvalumab dose
- History of allogenic organ transplant
- Active or prior autoimmune or inflammatory disorders except certain controlled conditions
- Uncontrolled illnesses or infections limiting compliance or increasing risk
- History of other primary malignancies unless adequately treated and not requiring treatment
- History of leptomeningeal carcinomatosis, malignant pleural effusion, or distant metastasis
- Suspected brain metastases without required imaging confirmation
- History of active primary immunodeficiency
- Active hepatitis B or C infection or positive HIV test
- Current or recent use of immunosuppressive medication except certain steroids
- Receipt of live vaccine within 30 days before first dose
- Pregnant or breastfeeding women or those unwilling to use effective birth control
- Known allergy to study drugs or excipients
- Prior treatment with durvalumab in clinical studies with certain immune-related adverse events
- Investigator judgment of unsuitability or likely noncompliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Toronto General Hospital
Toronto, Canada
Actively Recruiting
Research Team
M
Marc de Perrot, MD, FRCSC
CONTACT
F
Fatemeh Zaeimi, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here